May 13th 2025
Trump anticipates that the executive order will help lower drug prices by 30% to 80%.
May 12th 2025
The financial decision is due to customer demand stemming from the reshoring of drug supply services.
The President plans to sign an executive order on Monday morning to enforce the trade clause.
April 30th 2025
A seminar shares key observations and learnings from the first round of direct price negotiations.
April 29th 2025
IQVIA’s Doug Long offers a lay of the land, including trends and developing issues that are shaping the current market.
Observational Research: Choosing the right research approach for the right question
Industry hit a record low number of FDA OPDP actions in 2015
Office of Prescription Drug Promotion finds little to complain about
CMS publishes the long-awaited AMP rule
'Average Manufacturer Price' is now a mostly settled matter
Problems continue with FDA postmarketing review processes
Industry is doing better at filing studies, but the agency is falling behind reviews, says GAO
Eagle Pharmaceuticals gets a 505(b)(2) approval for docetaxel
Company partners with Teikoku for the latter's first marketed oncology product, and earns a milestone payment from Teva
Transparency-reporting trends in Europe
'European companies will not be able to follow the exact path to operational compliance as their US counterparts,' says IMS Health survey
FDA warns of a substandard compounding pharmacy--the latest of many notifications
Quality control remains a problem among compounding pharmacies, but bigger players are entering the field
Maintaining your digital marketing assets
Promotional content produced for, or derived from, digital media presents its own management and compliance complexities
NABP updates rogue-pharmacy data and its .pharmacy programs
Thousands of poorly regulated websites are targeted
What makes specialty pharmacies 'special'?
The growing number of certifications has become a competitive issue for SPPs bidding for Pharma's business
Medical marijuana looks for a place in conventional drug distribution
It's still early days in making medical marijuana--and cannabis-based pharmaceuticals--part of normal dispensing
FDA records a banner year in new-drug approvals, with 41
Roughly 40% are for rare diseases; PD-1 oncolytics capture industry attention
The Chief Compliance Officer role
Software and tech standards advance as pharma traceability deadline looms
GS1 Healthcare US publishes updated track-and-trace guidance; vendors revamp their offerings
HHS OIG looks deeply into copay cards for Medicare beneficiaries, finds potential kickback violations
Pharma companies will need to do more than rely on pharmacies' adjudication of claims
CVS/pharmacy earns URAC accreditation for 'community pharmacy'
First to gain newly established program reviewing therapy management and chronic care
Adopting the TAPA cargo security standards in the pharmaceutical industry
Securing your supply chain
Getting ready for Sunshine Act public data
How to prepare for reporting and utilizing published data for business and compliance purposes
HCPC awards 2013 Compliance Package of the Year to Noven Therapeutics
Innovation award goes to Mem-O-Ring, a pill-bottle attachment
Three new facilities are announced for UPS in Latin America
Mexico, Brazil and Chile will see new or expanded healthcare logistics capability
Cegedim survey updates industry response to aggregate-spending rules
Pharma companies assess their ongoing reporting capabilities
A brand, a generic, an OTC: Nexium (esomeprazole) will take many forms soon
AstraZeneca plots next moves
So you are 'in the cloud;' now what?
Getting to the 'future state' in cloud computing
University-based consortium will develop standards for biomarker-based diagnostics
Efforts of the National Biomarker Development Alliance will address the 'dismal' success rate of approved biomarker diagnostics
Fourteen compounding pharmacies have already applied for DQSA registration with FDA
Companies are positioning themselves as approved high-volume compounders
CMS posts Sunshine Act registration details
Consulting firm puts compliance front and center for clinical-stage drug developers
New 'emergent biopharma' service combines compliance with pricing, market access
Drug Quality and Security Act becomes law
Long-awaited track-and-trace law ushers in a new era of pharmaceutical supply-chain monitoring; compounding pharmacies get a new structure also
Finding the value in outsourced contract administration
The growing complexity of managed-markets contract support makes outsourcing a near-necessity for Small Pharma, and a better option for Big Pharma
House passes Drug Quality and Security Act; Senate passage is likely
Bill includes voluntary oversight by FDA of outsourced compounded pharmaceuticals, national distributor licensure, and a timetable for serialization and drug tracking